Phase III Study of EB103 T-Cell Therapy for Adults With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma Open-Label, Dose Escalation and Expansion Trial

What this Trial Is About

Researchers are evaluating an autologous T-cell therapy called EB103 in adults aged 18 years and older with relapsed or refractory B-cell Non-Hodgkins lymphoma NHL. This open-label Phase III trial aims to assess the safety of EB103 and determine the Recommended Phase II Dose RP2D, including a dose escalation phase followed by an expansion phase. The study is designed to better understand how EB103 may work in this patient population. The trial uses a traditional 33 dose escalation model where approximately six participants will receive escalating doses to find the RP2D. After establishing the RP2D, about fifteen more subjects will be treated at this dose during the expansion phase to confirm safety and evaluate preliminary effectiveness. EB103 involves using a participants own T cells, which are modified with a lentiviral vector to express the EB103 transgene. Participants will undergo assessments to monitor dose-limiting toxicities within 28 days, treatment-emergent adverse events, and laboratory abnormalities over 90 days. The study will also assess response rates, disease control, duration of response, progression-free and event-free survival, overall survival, and pharmacokinetic profiles of EB103 for up to two years. Researchers will carefully monitor safety and collect data throughout the study, which is expected to continue until December 2027.

T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)